Plum and mulberry juice concentrate in quality of life

A Phase III, Randomized, Open Label, Placebo-Controlled Clinical Study To Evaluate The Efficacy And Safety Of Renew For The Treatment Of Age Related Changes In Form, Function And Quality Of Life In Healthy Subiects

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002123

Enrollment

Registered

2011-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Plum and Mulberry Juice concentrate: Plum and Mulberry Juice concentrate will be taken 10 ml orally once dailly in morning for up to 90 consecutive days. Control Intervention1: Placebo

Eligibility

Inclusion criteria

Inclusion criteria: 1 Subject or legally acceptable representative is able to provide written informed consent prior to study. 2 Male and female healthy subjects of age between 40 to 70 years. 3 Serum insulin-like growth factor-1 concentrations less than 150 gram/desiLitre. 4 Free serum concentrations of thyroxine either endogenous or with thyroxine replacement therapy within the normal range. 5 Non diabetics only. 6 Willingness to comply with the study schedule and procedures.

Exclusion criteria

Exclusion criteria: 1.Subject with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion. 2.Subject with any other clinically significant disease which would have an impact on long-term nutritional status, bone mineralization or body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver disease, chronic severe renal disease and musculo-skeletal or neurologic disorders. 3.Glucose intolerant subject. 4.Subject with history of hypopituitarism, pituitary tumor, radiation of the head/neck, and evidence of partial or complete hypopituitarism (including GHD). 5.Subject with chromosomal disorders, disorders with a high predisposition to malignancy or complex syndromes associated with growth hormone deficiency. 6.Subject with uncontrolled hypertension, cardiac disease including CHF, edema forming states and chronic lung disease. 7.Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy (including CNS) irradiation is not exclusion as long as the subject has not had active disease for five years and is not receiving maintenance chemotherapy. 8.Corticosteroid replacement. 9.Past (within prior year) or concomitant use of recombinant hGH. 10.History of significant noncompliance with previous therapies. 11.Benign prostatic hypertrophy with PSA more than 4.0, prostate cancer and malignant breast disease. 12.Hypersensitivity to plum or white mulberry juices.

Design outcomes

Primary

Measure	Time frame
Changes in metabolic production of insulin like growth factor-1 (IGF-1)Timepoint: Day 0, Day 45 and Day 90	—

Secondary

Measure	Time frame
Improved body composition, Changes in Bone mineral density at day 0 and 90 days. Timepoint: Day 0, Day 45 and Day 90	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com919825585119

Outcome results